{"id":195,"date":"2020-02-06T17:08:17","date_gmt":"2020-02-06T21:08:17","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=195"},"modified":"2020-02-06T17:08:17","modified_gmt":"2020-02-06T21:08:17","slug":"fda-revises-policies-and-procedures-for-prioritization-of-andas-in-new-mapp","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2020\/02\/06\/fda-revises-policies-and-procedures-for-prioritization-of-andas-in-new-mapp\/","title":{"rendered":"FDA Revises Policies and Procedures for Prioritization of ANDAs in New MAPP"},"content":{"rendered":"<p>On January 30, 2020, the U.S. Food &amp; Drug Administration (FDA)\u00a0<a title=\"Prioritization of the Review of Original ANDAs, Amendments, and Supplements\" href=\"https:\/\/www.fda.gov\/media\/89061\/download\" target=\"_blank\" rel=\"noopener noreferrer\">issued<\/a>\u00a0a new Manual of Policies &amp; Procedures (MAPP) concerning how it will prioritize internal review of abbreviated new drug applications (ANDAs), amendments and supplements.<\/p>\n<p>Whether a submission qualifies for priority designation can mean a substantial difference in approval time. As the FDA explains, it \u201cmay grant an ANDA submission either a shorter review goal date or an expedited review\u201d if the submission satisfies a public health priority (or prioritization factor) described in the MAPP.<\/p>\n<p><a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_revises_policies_procedures_prioritization_andas_0220.html\">View the full <em>Alert<\/em> on the Duane Morris LLP website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On January 30, 2020, the U.S. Food &amp; Drug Administration (FDA)\u00a0issued\u00a0a new Manual of Policies &amp; Procedures (MAPP) concerning how it will prioritize internal review of abbreviated new drug applications (ANDAs), amendments and supplements. Whether a submission qualifies for priority designation can mean a substantial difference in approval time. As the FDA explains, it \u201cmay &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2020\/02\/06\/fda-revises-policies-and-procedures-for-prioritization-of-andas-in-new-mapp\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Revises Policies and Procedures for Prioritization of ANDAs in New MAPP&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[37,29,209,388,221,321,50,322],"ppma_author":[521],"class_list":["post-195","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-anda","tag-fda","tag-frederick-ball","tag-justin-stern","tag-life-sciences","tag-mapp","tag-pharma","tag-pharmaceuticals"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/195","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=195"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/195\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=195"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=195"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=195"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=195"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}